REAGENT SYSTEM #350HDL, SIGMA PROCEDURE
Device Facts
| Record ID | K790760 |
|---|---|
| Device Name | REAGENT SYSTEM #350HDL, SIGMA PROCEDURE |
| Applicant | Sigma Chemical Co. |
| Product Code | CHH · Clinical Chemistry |
| Decision Date | May 23, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1175 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
